Effect of Preoperative Fiber on Postoperative Bowel Function
Study Details
Study Description
Brief Summary
Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Post-operative constipation or delay in return to bowel function is a common concern among patients undergoing pelvic reconstructive surgery. A retrospective study reviewing all patient-initiated telephone calls in the postoperative period after pelvic reconstructive surgery found the most frequent concern among patients to be constipation. Moreover, prevention of constipation may help minimize unnecessary pressure and strain on the pelvic floor during post-operative recovery.
There are various strategies for managing post-operative constipation which typically involve medications including stool softeners, laxatives, or stool bulking agents. Several studies have examined the use of these postoperative regimens and have found a shortened time to first bowel movement (BM) with a combination of these medications when compared to placebo.Despite the use of these regimens, most patients do not have their first BM until the second or third postoperative day and this can result in significant distress, discomfort, and fecal impaction.
Postoperative constipation is a multifactorial process and an alternative approach involves consideration of the preoperative period. Preoperative defecation patterns can be a factor in the development of postoperative constipation. We are not aware of any studies looking at the effect of preoperative intervention on postoperative bowel function, particularly the use of preoperative fiber supplementation.
Psyllium fiber is a dietary supplement and stool bulking agent that stimulates peristalsis and improves bowel evacuation. The Western diet is low in fiber and women with pelvic organ prolapse have been found to have lower dietary intake of fiber when compared to controls.8 The primary objective of this study is to evaluate whether the use of preoperative psyllium fiber intake reduces time to first bowel movement after pelvic reconstructive surgery.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention - Received fiber Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. |
Dietary Supplement: Psyillium fiber
Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery
|
No Intervention: Control - Did not receive fiber Participants did not take any preoperative fiber. |
Outcome Measures
Primary Outcome Measures
- Time to First Bowel Movement After Surgery [Within 7 days]
Date and time of first bowel movement captured via postoperative bowel diary
Secondary Outcome Measures
- Pain Associated With First Bowel Movement After Surgery [Within 7 days]
Pain captured with visual analog scale with 0 being no pain and 10 being worst pain
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women undergoing prolapse repair with or without hysterectomy on the University of Massachusetts urogynecology service
Exclusion Criteria:
-
Unable to provide consent
-
Under 18 years of age
-
Pregnant women
-
Prisoners
-
As our validated questionnaires are only available in English, we are unable to offer study participation to Non-English speaking subjects
-
Because these conditions intrinsically affect bowel function, women with the following will be excluded: history of inflammatory bowel disease, colorectal cancer, rectovaginal fistula, sigmoid resection or rectal surgery
-
Because the use of motility agents can affect bowel function and stool transit, women using motility agents such as linaclotide will be excluded.
-
Concurrent bowel surgery due to potential effect on the surgical field
-
Concurrent anal sphincteroplasty due to potential effect on the surgical field
-
Insulin-dependent diabetes mellitus with known gastroparesis as this would affect transit of fiber supplement
-
Patients with a history of phenylketonuria as the psyllium fiber supplement we will be using contains phenylalanine
-
History of placement of sacral neuromodulating device for indication of fecal incontinence, as this would affect bowel function
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01605 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
Investigators
- Principal Investigator: Deepali Maheshwari, DO, MPH, UMass Chan Medical School
Study Documents (Full-Text)
More Information
Publications
- Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91.
- Ballard A, Parker-Autry C, Lin CP, Markland AD, Ellington DR, Richter HE. Postoperative bowel function, symptoms, and habits in women after vaginal reconstructive surgery. Int Urogynecol J. 2015 Jun;26(6):817-21. doi: 10.1007/s00192-015-2634-8. Epub 2015 Feb 12.
- McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529.
- Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
- Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636.
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Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Intervention - Received Fiber | Control - Did Not Receive Fiber |
---|---|---|
Arm/Group Description | Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. | Participants did not take any preoperative fiber. |
Period Title: Overall Study | ||
STARTED | 41 | 43 |
COMPLETED | 35 | 36 |
NOT COMPLETED | 6 | 7 |
Baseline Characteristics
Arm/Group Title | Intervention - Received Fiber | Control - Did Not Receive Fiber | Total |
---|---|---|---|
Arm/Group Description | Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. | Participants did not take any preoperative fiber. | Total of all reporting groups |
Overall Participants | 35 | 36 | 71 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
60.7
(11.9)
|
60
(10.3)
|
60.3
(11.0)
|
Sex: Female, Male (Count of Participants) | |||
Female |
35
100%
|
36
100%
|
71
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
5.7%
|
3
8.3%
|
5
7%
|
Not Hispanic or Latino |
33
94.3%
|
33
91.7%
|
66
93%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
2.9%
|
2
5.6%
|
3
4.2%
|
White |
32
91.4%
|
31
86.1%
|
63
88.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
2
5.7%
|
3
8.3%
|
5
7%
|
PAC-SYM (units on a scale) [Mean (Full Range) ] | |||
Mean (Full Range) [units on a scale] |
0.5
|
0.3
|
0.3
|
Outcome Measures
Title | Time to First Bowel Movement After Surgery |
---|---|
Description | Date and time of first bowel movement captured via postoperative bowel diary |
Time Frame | Within 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Intervention - Received Fiber | Control - Did Not Receive Fiber |
---|---|---|
Arm/Group Description | Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. | Participants did not take any preoperative fiber. |
Measure Participants | 35 | 36 |
Mean (Standard Deviation) [hours] |
66.5
(22.7)
|
68.3
(25)
|
Title | Pain Associated With First Bowel Movement After Surgery |
---|---|
Description | Pain captured with visual analog scale with 0 being no pain and 10 being worst pain |
Time Frame | Within 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Intervention - Received Fiber | Control - Did Not Receive Fiber |
---|---|---|
Arm/Group Description | Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. | Participants did not take any preoperative fiber. |
Measure Participants | 35 | 36 |
Median (Full Range) [score on a scale] |
2.0
|
2.0
|
Adverse Events
Time Frame | 2 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Intervention - Received Fiber | Control - Did Not Receive Fiber | ||
Arm/Group Description | Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery. | Participants did not take any preoperative fiber. | ||
All Cause Mortality |
||||
Intervention - Received Fiber | Control - Did Not Receive Fiber | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) | 0/36 (0%) | ||
Serious Adverse Events |
||||
Intervention - Received Fiber | Control - Did Not Receive Fiber | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) | 0/36 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Intervention - Received Fiber | Control - Did Not Receive Fiber | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/35 (0%) | 0/36 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Deepali Maheshwari |
---|---|
Organization | UMass Chan Medical School |
Phone | 4137948764 |
deepali.mahesh@gmail.com |
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